|CLASS NOTES (Under
QUALITY ASSURANCE IN BLOOD BANKING
When discussing Quality Programs it includes:
- Quality Control
- Quality Assurance
For Blood Banking Quality Programs are
essential requirements of 2 Federal
- Centers for Medicare and Medicaid Systems (CMS),
formerly HCFA, under CLIA-88 which covers all Clinical Laboratory
activities and related federal payments
- Food and Drug
Administration that has the following concerns:
- Responsibilities of the blood product requirements
(anticoagulants and preservatives, shelf life etc.)
- Specific requirements related to independent quality control and quality
assurance for overall quality of blood products and the processes
related to dispersion of those products.
A number of accrediting agents have quality requirements
- American Association of Blood Banks (Blood Banks
and Transfusion Services)
Commission on the Accreditation of Healthcare Organizations
- College of
AABB Quality System Essentials & FDA Guidelines
for Quality Assurance in Blood Establishments
Organization: active support of quality systems
must be place for the following procedures;
SOP's - Standard Operating Procedures
Training plans and development of procedures
Approval of lot release of reagents and quality control reagents
Review and approval of practices relating to personnel, equipment,
selection of suppliers, process control, final inspection and handling
nonconforming components, methods in place for handling incidents,
errors, and accidents.
- Methods for hiring of qualified personnel needs
to be in place
- Job descriptions for all positions need to exist
and be available
program and full documentation of that training for new and continuous
employees. Whenever a new procedure or instrument is implemented a
training program needs to be in place.
- Regular competency evaluations including direct
observation and documentation of such must occur.
- Validation of new equipment
- Calibration and preventative maintenance
including standard equipment like refrigerators, complex equipment
and computer systems
- Continual monitoring of blood bank refrigerators
extremely important in both blood centers and transfusion services
The Food and Drug Administration licenses blood bank
reagents, antisera, reagent cells, other commercial additives.
Specific criteria is set for both the specificity and the potency of the
reagents. For example, anti-A will only react with A cells and will
demonstrate a 3-4+ reaction with A1 reagent cells. Once
the reagents have met the FDA criteria for specificity and potency, a
license number is assigned. Along with the license number and lot
number an expiration date is also placed on the labeled. Other than
very rare antisera, routine blood bank reagents CANNOT be used after the
expiration date. Daily quality control testing needs to be done for
ABO, Rh, and Antibody Screening. Typing antisera for other red cell
antigens will be tested when performing the antigen testing on the patient
and donors since this test is not done each day.
Each manufacturer is required to provide a product
insert for each reagent. The product insert needs to include the
- Reagent's description
- Proper use procedures
- What to expect in regards to performance
When a new shipment of reagents is received, the
product insert needs to be reviewed and any changes in the standard
operating procedure needs to incorporated into the lab's procedure before
the reagents are used by the laboratory.
Total compliance with the manufacturer's directions must be followed.
According to AABB, the following criteria and
documentation must be in place in the individual laboratory.
- List of
critical supplies and services
- Clearly defined requirements
- Evaluation of suppliers qualifications to meet requirements
requirements for manufacturer mechanisms to notify facility of changes
- Prior to use of incoming supplies they need to
- Determination needs to be made relating to
whether they are satisfactory for intended use.
- Documentation of package,
storage and transportation
- Documentation of testing needs to done by
facility before being put into use and prior to each use for reagents
related to ABO, Rh, antibody screening and infectious diseases before
being used for patient or donor testing. (See attached worksheet for daily
QC of blood bank reagents.)
Process control, final inspection, and
- Process control includes
Development of SOP
- Control of changes in policies,
processes or procedures
- Acceptance testing to new/revised software
involved in blood bank procedures
- Validation of new policies, processes
- Monitoring and control of production processes
- Participation in proficiency testing appropriate for each testing system
- Established QC procedures for supplies and
- Supplier qualifications and product
specification need to be in place
- Control processes for nonconforming blood and blood
components and products.
Documents and records (4 levels)
Documents and records have 4 levels
- Policies (Level 1) relate to "What to do"
in response to various situations
- Processes (Level 2) relate to "How it happens"
- Procedures (Level 3) "How to do it"
- Forms/Records, Supporting Documents etc. (Level
4) that need to be completed when you are performing the procedures and
following the processes and policies.
Incidents, errors, and accidents
In order to continuous improve methods need to be
in place to detect incidents, errors, and accidents. Therefore the
follow should be in place:
- Process to capture incidents, errors etc.
- If incident occurs, the severity of the incident
is determined by the facility
- If it is a one-time incident: "What is the
likelihood it will happen again?" and what to do about it if it could
- If there are multiple similar incidents "What
might be the root cause?"
- Develop processes for continuous improvement to
help eliminate both one-time incidents and multiple similar incidents.
Assessments: internal and
A Quality Assessment Program includes both internal
and external assessment:
- Internal assessment includes blood usage review committees
within a hospital (transfusion audits) or institutional QA teams
- External assessments includes inspections, surveys, proficiency surveys
performed by agencies like the FDA, AABB, and CAP
Corrective actions that are educational not punitive
Yearly reports relating to QA and CQI committees
Although both transfusion services and blood
centers are primarily concern with safe transfusions and related issues,
there also needs to be processes in place related to employee safety
therefore the following needs should be met:
- Compliance with OSHA requirements: chemical and
- Disaster preparedness
- Adequate space and ventilation
- Adequate sanitation and water systems etc.
- Evaluations of limitations of physical structure
prior to implementation of new equipment or processes
OBJECTIVES - Quality Assurance in Blood Banking
- Identify the agencies having requirements for
quality assurance in Blood Centers, Transfusion Centers and Blood
- Explain the value of the following
b) Personnel Policies
c) Standard Processes and their
d) Equipment and supplies contracting,